Oasis eTMF Standard Technical Committee
November 17 2014
Meeting Minutes
1. Roll Call – Members and Observers Present (alpha order)
Jennifer Alpert Palchak, CareLex; Peter Alterman, SAFE-Biopharma; Aliaa Badr, CareLex; Lou Chappuie, individual; Chris Ibell, SureClinical; ; Rich Lustig, Oracle; Karen McCarthy Schau, Paragon Solutions; Catherine Schmidt, Sterling Bio; Zack Schmidt, SureClinical;; Mead Walker, HL7; Trish Whetzel, , SureClinical advisor. Chris McSpirit, Michael Agard
2. Approval of Minutes
Motion: Peter Alterman moved to accept the minutes of the meetings on October 6 and November 3, the motion was seconded by Karen McCarthy Schau and the minutes were approved/ discussed and approved/edited and approved.
3. Review of vocabulary material out for ballot
Discussion of the previously distributed Slates: W33, W34, W35, W36, W37, W38. Are there any items to be pulled from these slates? No items were pulled from any of the slates.
Motion: Michael Agard moved to approve the comment resolutions for the slates: W33, W34, W35, W36, W37, W38. The motion was seconded by Rich Lustig.
The motion passed without opposition.
Action: No action proposed.
4. New Business
No new business was proposed by the group.
A point of discussion is a paper (Reflection paper on GCP compliance in relation to trial 6 master files (paper and/or electronic) for management, audit and inspection of clinical trials accessible at http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/02/WC500138893.pdf) issued by the European Medicine Agency that addresses issues for clinical trial submissions. The paper took up the question of content within the trial record of data to be maintained separate (investigator controlled and sponsor controlled) to make it possible to limit access to the material.
5. Proposed Meeting Agenda for ____:
Roll Call
Approval of Minutes
(e.g.)Metadata vocabulary edit proposal
(e.g.)Specification edit proposals
New Business
Action Items from this meeting: None
Members with issues for the TC to address are asked to please post them to the eTMF TC Issues List in preparation for meetings.
Members can forward agenda items to Zack at .
Meeting adjourned at 9:43 a.m. PT (12:43 ET)
Minutes submitted by Mead Walker (secretary)